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A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is (DETECT)

Primary Purpose

Growth Hormone Deficiency

Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Macimorelin
Arginine
Clonidine
Sponsored by
AEterna Zentaris
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Growth Hormone Deficiency focused on measuring childhood-onset growth hormone deficiency, diagnosis of growth hormone deficiency, diagnosis of childhood-onset growth hormone deficiency, diagnostic test for growth hormone deficiency

Eligibility Criteria

2 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Informed consent of subject, parent(s) or legally acceptable representative (LAR) of subject and child assent, if appropriate, must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial.
  2. Male and female pediatric subjects from 2 to less than 18 years of age at the time of signing informed consent.
  3. Indication for the performance of growth hormone stimulation test.
  4. Presence of a height measurement minimum 6 and maximum 18 months prior to screening.

Exclusion Criteria:

  1. Established diagnosis of a disease that is sufficient to explain growth deficiency or metabolic disorders that are also associated with short stature (e.g., Turner syndrome, skeletal dysplasia's, celiac disease, etc.).
  2. Ongoing growth hormone therapy.
  3. Presence of hypothyroidism and/or adrenal insufficiency without adequate and stable replacement therapy treatment for at least 30 days prior to first GHST.
  4. Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g., somatostatin analogues, clonidine, levodopa and dopamine agonists) or provoking the release of somatostatin (antimuscarinic agents e.g., atropine).
  5. Medical history of ongoing clinically symptomatic psychiatric disorders.
  6. 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds, prolongation of the QTc interval over 450 milliseconds, or any other clinically significant abnormal electrocardiogram results at the V2 pre-dose electrocardiogram (ECG) as judged by the investigator.
  7. Previous participation in this trial. Participation is defined as signed informed consent.
  8. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening.
  9. Known or suspected hypersensitivity to trial product(s) or related products;
  10. Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol.
  11. Concomitant treatment with any drugs that might prolong QT/QTc Note: A subject who receives such treatment will not be a candidate for this study, if his/her condition does not allow for a treatment-free period of at least 5 elimination half-lives of the drug that might prolong QT/QTc before the GHST;
  12. Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (aspartate amino transferase (AST), alkaline phosphatase (ALT), gamma-glutamyl transferase (GGT) > 2.5 x upper limit of normal (ULN); creatinine or bilirubin > 1.5x ULN);
  13. Current active malignancy other than non-melanoma skin cancer;
  14. Female of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
  15. Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice).
  16. Lack of ability or willingness to give informed consent by the subject and/or his/her legal representative;
  17. Anticipated non-availability for trial visits/procedures.

Sites / Locations

  • Angel Wing Clinic For Children With DiabetesRecruiting
  • Pediatric Endocrine Associates, p.c.Recruiting
  • John Hopkins All Children's HospitalRecruiting
  • Emory Healthcare-Children's CenterRecruiting
  • St. Luke's Children's EndocrinologyRecruiting
  • University of Minnesota, Masonic Children's HospitalRecruiting
  • The Children's Mercy Hospital - BroadwayRecruiting
  • Icahn School of Medicine at Mount SinaiRecruiting
  • UNC HospitalsRecruiting
  • Diabetes and Glandular Disease Clinic, PA
  • Multicare Health SystemRecruiting
  • JSC Maritime HospitalRecruiting
  • National Institute of EndocrinologyRecruiting
  • TSMU Givi Jvania Pediatric Academic ClinikRecruiting
  • Evangelisches Klinikum BethelRecruiting
  • Ospedale Pediatrico G. SalesiRecruiting
  • Azienda Ospedaliero-Universitaria Anna MeyerRecruiting
  • Osp. dei Bambini V. Buzzi, ASST Fatebenefratelli SaccoRecruiting
  • Azienda Ospedaliero-Universitaria di Parma Ospedale dei Bambini Pietro Barilla, Clinica PediatricaRecruiting
  • IRCCS Ospedale Pediatrico Bambino GesùRecruiting
  • MED-POLONIA Sp.z o.o.Recruiting
  • Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w RzeszowieRecruiting
  • SPSK Nr 1 im. prof. Tadeusza Sokolowskiego PUM
  • Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we WroclawiuRecruiting
  • Cen Med de Diagn si Trat Amb NEOMEDRecruiting
  • Institutul de Endocrinologie "C.I. Parhon"Recruiting
  • Sana MonitoringRecruiting
  • Medicover HospitalsRecruiting
  • Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" ConstantaRecruiting
  • Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" IasiRecruiting
  • Spitalul Cl. de Urgenta pentru Copii Louis Turcanu TimisoaraRecruiting
  • Spitalul Clinic Judetean MuresRecruiting
  • University children's clinic Belgrade - Department of EndocrinologyRecruiting
  • Clinical Center Nis - Clinic for Children's Internal MedicineRecruiting
  • Institute for Child and Youth Health Care of Vojvodina - EndocrinologyRecruiting
  • National Institute of Endocrinology and DiabetologyRecruiting
  • Univerzitetni Klinicni Center Ljubljana - PediatricsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

standard GHST order randomized: arginine - clonidine

standard GHST order randomized: clonidine - arginine

Arm Description

At visit 2 (V2), all subjects will perform the macimorelin GHST and will be randomized 1:1 to the order of the clonidine and arginine GHSTs at visit 3 (V3) and visit 4 (V4). In this arm, those subjects will be presented which will have been randomized to the arginine GHST at V3 and the clonidine GHST at V4. At visit 5 (V5) all subjects will perform the macimorelin GHST.

At V2, all subjects will perform the macimorelin GHST and will be randomized 1:1 to the order of the clonidine and arginine GHSTs at V3 and V4. In this arm, those subjects will be presented which will have been randomized to the clonidine GHST at V3 and to the arginine GHST at V4. At V5 all subjects will perform the macimorelin GHST.

Outcomes

Primary Outcome Measures

Area under the Receiver Operator Characteristic curve (ROC AUC) based on GH concentration during GHST following macimorelin administration
Assuming the outcome of GHD status adjudication final clinical diagnosis as the "true" GHD status, the diagnostic efficacy (estimated sensitivity, specificity, misclassification) of the macimorelin GHST will be based on the area under the receiver operating characteristic curve (ROC AUC).

Secondary Outcome Measures

Sensitivity for the macimorelin GHST
Sensitivity (confirmatory secondary endpoint) will be derived from the empirical ROC plot using this GH cut-off point.
Specificity for the macimorelin GHST
Specificity (confirmatory secondary endpoint) will be derived from the empirical ROC plot using this GH cut-off point.
Overall agreement between the outcome of the macimorelin GHST and the combined outcome from the 2 standard GHSTs
Agreement between the outcome of macimorelin and the combined outcome of the 2 standard GHSTs will be evaluated by 'percent overall agreement'.

Full Information

First Posted
March 3, 2021
Last Updated
May 3, 2023
Sponsor
AEterna Zentaris
Collaborators
Novo Nordisk A/S
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1. Study Identification

Unique Protocol Identification Number
NCT04786873
Brief Title
A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is
Acronym
DETECT
Official Title
Multicenter, Open Label Trial to Investigate the Efficacy and Safety of a Single Oral Dose of 1.0 mg/kg Macimorelin Acetate as Growth Hormone Stimulation Test (GHST) in Pediatric Patients With Suspected Growth Hormone Deficiency (GHD)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 16, 2021 (Actual)
Primary Completion Date
September 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AEterna Zentaris
Collaborators
Novo Nordisk A/S

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
This research study will find out if a new growth hormone stimulation test is safe and works as well as other tests to diagnose growth hormone deficiency (GHD) in children. The stimulation test will use a new growth hormone stimulating substance called macimorelin. By now, only adults in the USA can get this new stimulation test. The results of this study are expected to help children and teenagers with suspected GHD to get the macimorelin stimulation test. The macimorelin test will be compared to a clonidine and an arginine test. Both are known standard stimulation tests. Altogether two macimorelin tests are planned to be performed in the study, to show how repeatable macimorelin tests results are (under a set of similar conditions).
Detailed Description
Each study participant (patient) will have 5 to 6 visits in total with the study doctor. The study will last for about 1 to 4 months, dependent on how close the visits are done. At the visits 2, 3, 4 and 5, the patient will get a stimulation test done and blood samples will be taken. At those 4 visits, the patient will have either to drink a macimorelin drink, take some clonidine tablets or get an arginine infusion. In total, the patient will get 2 macimorelin, 1 clonidine and 1 arginine test done. The level of growth hormone (GH) will be measured 4 times during the clonidine and during the arginine test and 5 times during the macimorelin test. After the test, questions on the test tolerability will be captured from patients and parents. After the arginine test, a urine dipstick test is to be done by the patient at home.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Growth Hormone Deficiency
Keywords
childhood-onset growth hormone deficiency, diagnosis of growth hormone deficiency, diagnosis of childhood-onset growth hormone deficiency, diagnostic test for growth hormone deficiency

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Model Description
This is an open label, single-dose trial to determine the diagnostic efficacy and safety of macimorelin in pediatric subjects aged 2 to less than 18 years of age in whom, based on auxological and clinical criteria, growth hormone stimulation test (GHST) is indicated due to suspected growth hormone deficiency. Four GHSTs will be conducted during the trial: the macimorelin GHST will be performed twice, and arginine and clonidine standard GHSTs will be performed once each. The macimorelin GHST will be administered at the beginning of the trial and after serial performance of the two different standard GHSTs. The macimorelin GHSTs will be performed twice to show repeatability of the macimorelin GHST. All subjects will be randomized 1:1 to the order of the arginine and clonidine GHSTs, and in a crossover manner all subjects will receive both these GHSTs.
Masking
Outcomes Assessor
Masking Description
This study is open label. Masking is performed with regard to the GHST results (i.e. growth hormone (GH) values). GH values from all GHSTs will be assessed centrally by a central lab: GH values following the two standard GHSTs at V3 and V4 will not be disclosed to the trial site prior to the end of V5 (i.e., the second macimorelin GHST). To avoid bias in the final diagnostic assessments by the investigators, macimorelin pharmacodynamic (PD) data will remain blinded to the trial sites, clinical research associates (CRAs), and trial management at contract research organization (CRO) and Sponsor until trial closure. An Independent Adjudication Committee (IAC) is established to perform ongoing blinded adjudication of subjects' growth hormone deficiency status. The IAC will adjudicate in a consistent manner by use of pre-defined definitions and guidelines.
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
standard GHST order randomized: arginine - clonidine
Arm Type
Active Comparator
Arm Description
At visit 2 (V2), all subjects will perform the macimorelin GHST and will be randomized 1:1 to the order of the clonidine and arginine GHSTs at visit 3 (V3) and visit 4 (V4). In this arm, those subjects will be presented which will have been randomized to the arginine GHST at V3 and the clonidine GHST at V4. At visit 5 (V5) all subjects will perform the macimorelin GHST.
Arm Title
standard GHST order randomized: clonidine - arginine
Arm Type
Active Comparator
Arm Description
At V2, all subjects will perform the macimorelin GHST and will be randomized 1:1 to the order of the clonidine and arginine GHSTs at V3 and V4. In this arm, those subjects will be presented which will have been randomized to the clonidine GHST at V3 and to the arginine GHST at V4. At V5 all subjects will perform the macimorelin GHST.
Intervention Type
Drug
Intervention Name(s)
Macimorelin
Other Intervention Name(s)
Macrilen, AEZS-130, Macimorelin GHST, Macimorelin test, Macrilen GHST, Macrilen test
Intervention Description
Dosage form: granules for oral solution, Dosage: 1.0 mg/kg body weight, Frequency and duration: single oral dose administration. Macimorelin will be supplied in single-use aluminum pouches (synonymous: sachets) each containing 63.6 mg macimorelin as acetate, which provide 0.5 mg/mL of macimorelin when dissolved in 120 mL of water. The excess amount of 3.6 mg represents an overfill, which is needed to obtain the target concentration.
Intervention Type
Diagnostic Test
Intervention Name(s)
Arginine
Other Intervention Name(s)
R-Gene 10, arginine test, arginine GHST
Intervention Description
For the arginine GHST, R-Gene® 10 from Pfizer will be provided as labelled investigational medicinal product (IMP). After an overnight fast, soluble arginine hydrochloride (0.5 g/kg) will be given i.v. as an infusion with an infusion duration of 30 min.
Intervention Type
Diagnostic Test
Intervention Name(s)
Clonidine
Other Intervention Name(s)
Catapressan 75, Clonidine test, Clonidine GHST
Intervention Description
For the clonidine GHST, CATAPRESAN® 75 tablets (Boehringer Ingelheim) will be provided as labelled IMP. Each tablet contains 75 ug clonidine hydrochloride. The tablets will be provided in boxes containing 10 tablets. The target dose is 0.15 mg/m2 body surface with a dose range of 0.08 - 0.15 mg/m2. Maximum dose will be 0.25 mg. After an overnight fast, clonidine (0.15 mg/m2 body surface) will be given orally.
Primary Outcome Measure Information:
Title
Area under the Receiver Operator Characteristic curve (ROC AUC) based on GH concentration during GHST following macimorelin administration
Description
Assuming the outcome of GHD status adjudication final clinical diagnosis as the "true" GHD status, the diagnostic efficacy (estimated sensitivity, specificity, misclassification) of the macimorelin GHST will be based on the area under the receiver operating characteristic curve (ROC AUC).
Time Frame
Derived from Cmax GH measurements collected in the time frame from 0 to 90 minutes after initial macimorelin GHST (visit 2 (day 0)) and GH adjudication status performed by the adjudication committee after visit 4 (between day 11 and day 58)).
Secondary Outcome Measure Information:
Title
Sensitivity for the macimorelin GHST
Description
Sensitivity (confirmatory secondary endpoint) will be derived from the empirical ROC plot using this GH cut-off point.
Time Frame
Derived from Cmax GH measurements collected in the time frame from 0 to 90 minutes after initial macimorelin GHST (visit 2 (day 0)) and GH adjudication status performed by the adjudication committee after visit 4 (between day 11 and day 58)).
Title
Specificity for the macimorelin GHST
Description
Specificity (confirmatory secondary endpoint) will be derived from the empirical ROC plot using this GH cut-off point.
Time Frame
Derived from Cmax GH measurements collected in the time frame from 0 to 90 minutes after initial macimorelin GHST (visit 2 (day 0)) and GH adjudication status performed by the adjudication committee after visit 4 (between day 11 and day 58)).
Title
Overall agreement between the outcome of the macimorelin GHST and the combined outcome from the 2 standard GHSTs
Description
Agreement between the outcome of macimorelin and the combined outcome of the 2 standard GHSTs will be evaluated by 'percent overall agreement'.
Time Frame
Visit 4 (between day 11 and day 58)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Informed consent of subject, parent(s) or legally acceptable representative (LAR) of subject and child assent, if appropriate, must be obtained before any trial-related activities. Trial-related activities are any procedures that are carried out as part of the trial, including activities to determine suitability for the trial. Male and female pediatric subjects from 2 to less than 18 years of age at the time of signing informed consent. Indication for the performance of growth hormone stimulation test. Presence of a height measurement minimum 6 and maximum 18 months prior to screening. Exclusion Criteria: Established diagnosis of a disease that is sufficient to explain growth deficiency or metabolic disorders that are also associated with short stature (e.g., Turner syndrome, skeletal dysplasia's, celiac disease, etc.). Ongoing growth hormone therapy. Presence of hypothyroidism and/or adrenal insufficiency without adequate and stable replacement therapy treatment for at least 30 days prior to first GHST. Treatment with drugs directly affecting the pituitary secretion of somatotropin (e.g., somatostatin analogues, clonidine, levodopa and dopamine agonists) or provoking the release of somatostatin (antimuscarinic agents e.g., atropine). Medical history of ongoing clinically symptomatic psychiatric disorders. 2nd or 3rd degree atrioventricular-block, prolongation of the QRS complex over 120 milliseconds, prolongation of the QTc interval over 450 milliseconds, or any other clinically significant abnormal electrocardiogram results at the V2 pre-dose electrocardiogram (ECG) as judged by the investigator. Previous participation in this trial. Participation is defined as signed informed consent. Participation in any clinical trial of an approved or non-approved investigational medicinal product within 30 days before screening. Known or suspected hypersensitivity to trial product(s) or related products; Any disorder, which in the investigator's opinion might jeopardize subject's safety or compliance with the protocol. Concomitant treatment with any drugs that might prolong QT/QTc Note: A subject who receives such treatment will not be a candidate for this study, if his/her condition does not allow for a treatment-free period of at least 5 elimination half-lives of the drug that might prolong QT/QTc before the GHST; Elevation of laboratory parameters indicating hepatic or renal dysfunction or damage (aspartate amino transferase (AST), alkaline phosphatase (ALT), gamma-glutamyl transferase (GGT) > 2.5 x upper limit of normal (ULN); creatinine or bilirubin > 1.5x ULN); Current active malignancy other than non-melanoma skin cancer; Female of child-bearing potential and not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Male of reproductive age who or whose partner(s) is not using an adequate contraceptive method (adequate contraceptive measures as required by local regulation or practice). Lack of ability or willingness to give informed consent by the subject and/or his/her legal representative; Anticipated non-availability for trial visits/procedures.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Nicola K Ammer, MD
Phone
+496942602
Ext
3472
Email
nammer@aezsinc.com
First Name & Middle Initial & Last Name or Official Title & Degree
Beate Aue-Schuster
Phone
+496942602
Ext
3465
Email
baue@aezsinc.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nicola K Ammer, MD
Organizational Affiliation
AEterna Zentaris
Official's Role
Study Director
Facility Information:
Facility Name
Angel Wing Clinic For Children With Diabetes
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marc Wheeler, MD
Facility Name
Pediatric Endocrine Associates, p.c.
City
Greenwood Village
State/Province
Colorado
ZIP/Postal Code
80111
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sunil Nayak, MD
Facility Name
John Hopkins All Children's Hospital
City
Saint Petersburg
State/Province
Florida
ZIP/Postal Code
33701
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jose Canas, MD
Facility Name
Emory Healthcare-Children's Center
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30329
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Eric Felner, MD
Facility Name
St. Luke's Children's Endocrinology
City
Boise
State/Province
Idaho
ZIP/Postal Code
83712
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniel Flynn, MD
Facility Name
University of Minnesota, Masonic Children's Hospital
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55454
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bradley S. Miller, MD
Facility Name
The Children's Mercy Hospital - Broadway
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64108
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wayne Moore, MD
Facility Name
Icahn School of Medicine at Mount Sinai
City
New York
State/Province
New York
ZIP/Postal Code
10129
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Robert Rapaport, MD
Facility Name
UNC Hospitals
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nina Jain, MD
Facility Name
Diabetes and Glandular Disease Clinic, PA
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Individual Site Status
Withdrawn
Facility Name
Multicare Health System
City
Tacoma
State/Province
Washington
ZIP/Postal Code
98405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Bhuvana Sunil, MD
Facility Name
JSC Maritime Hospital
City
Batumi
ZIP/Postal Code
0179
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maia Rekhviashvili, MD
Facility Name
National Institute of Endocrinology
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elene Giorgadze, MD
Facility Name
TSMU Givi Jvania Pediatric Academic Clinik
City
Tbilisi
ZIP/Postal Code
0159
Country
Georgia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marine Gordeladze, MD
Facility Name
Evangelisches Klinikum Bethel
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Norbert Jorch, MD
Facility Name
Ospedale Pediatrico G. Salesi
City
Ancona
ZIP/Postal Code
60126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Valentino Cherubini, MD
Facility Name
Azienda Ospedaliero-Universitaria Anna Meyer
City
Firenze
ZIP/Postal Code
50139
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Stefano Stagi, MD
Facility Name
Osp. dei Bambini V. Buzzi, ASST Fatebenefratelli Sacco
City
Milano
ZIP/Postal Code
20154
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chiara Mameli, MD
Facility Name
Azienda Ospedaliero-Universitaria di Parma Ospedale dei Bambini Pietro Barilla, Clinica Pediatrica
City
Parma
ZIP/Postal Code
43100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanna Esposito, MD
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesù
City
Roma
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marco Cappa, MD
Facility Name
MED-POLONIA Sp.z o.o.
City
Poznań
ZIP/Postal Code
60-693
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marek Niedziela, MD
Facility Name
Kliniczny Szpital Wojewodzki nr 2 im. Sw. Jadwigi Krolowej w Rzeszowie
City
Rzeszów
ZIP/Postal Code
35-301
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Artur Mazur, MD
Facility Name
SPSK Nr 1 im. prof. Tadeusza Sokolowskiego PUM
City
Szczecin
ZIP/Postal Code
71252
Country
Poland
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elżbieta Petriczko, MD
Facility Name
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wroclawiu
City
Wrocław
ZIP/Postal Code
50368
Country
Poland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anna Noczynska, MD
Facility Name
Cen Med de Diagn si Trat Amb NEOMED
City
Braşov
ZIP/Postal Code
500283
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oana Capraru, MD
Facility Name
Institutul de Endocrinologie "C.I. Parhon"
City
Bucharest
ZIP/Postal Code
10587
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Corin Badiu, MD
Facility Name
Sana Monitoring
City
Bucuresti
ZIP/Postal Code
011025
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dan Peretianu, MD
Facility Name
Medicover Hospitals
City
Bucuresti
ZIP/Postal Code
013982
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina DUMITRESCU, MD
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Apostol Andrei" Constanta
City
Constanţa
ZIP/Postal Code
900591
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Mihai, MD
Facility Name
Spitalul Clinic Judetean de Urgenta "Sf. Spiridon" Iasi
City
Iaşi
ZIP/Postal Code
700111
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Cristina Preda, MD
Facility Name
Spitalul Cl. de Urgenta pentru Copii Louis Turcanu Timisoara
City
Timişoara
ZIP/Postal Code
300011
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Otilia Marginean, MD
Facility Name
Spitalul Clinic Judetean Mures
City
Târgu-Mureş
ZIP/Postal Code
540072
Country
Romania
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ionela Pascanu, MD
Facility Name
University children's clinic Belgrade - Department of Endocrinology
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vera Zdravkovic, MD
Facility Name
Clinical Center Nis - Clinic for Children's Internal Medicine
City
Niš
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Stankovic, MD
Facility Name
Institute for Child and Youth Health Care of Vojvodina - Endocrinology
City
Novi Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ivana Vorgucin, MD
First Name & Middle Initial & Last Name & Degree
Dragan Katanic, MD
Facility Name
National Institute of Endocrinology and Diabetology
City
Ľubochňa
ZIP/Postal Code
03491
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miriam Kuricova, MD
Facility Name
Univerzitetni Klinicni Center Ljubljana - Pediatrics
City
Ljubljana
ZIP/Postal Code
1000
Country
Slovenia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tadej Battelino, MD

12. IPD Sharing Statement

Learn more about this trial

A Research Study of How Well Macimorelin Works to Find Out if Children Have a Lack of Growth Hormone and How Safe it is

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